Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Neoplasms

Digestive System Diseases

Rare Diseases

Obesity

Diabetes Mellitus

Diabetes Mellitus, Type 2

Stomach Neoplasms

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer

The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).

Long limb Roux-en-Y reconstruction after subtotal gastrectomy

The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).

Conventional Roux-en-Y reconstruction after subtotal gastrectomy

The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)

Billroth II reconstruction after subtotal gastrectomy

Sungsoo Park, MD, PhD

Yeongkeun Kwon, MD, PhD

This is a prospective, multi-center, randomized controlled trial to compare Billroth II reconstruction versus conventional Roux-en-Y reconstruction versus long limb Roux-en-Y reconstruction for glycemic control in patients with concurrent type 2 diabetes and gastric cancer.

Billroth I, Billroth II, or Roux-en-Y procedure follows gastrectomy to reconstruct the gastrointestinal tract. Billroth I procedure restores the normal configuration of the gastrointestinal tract and Billroth II and Roux-en-Y procedure involve the creation of duodenal switch which is thought to be responsible for metabolic effects by altering enteric hormones. Accordingly, several retrospective studies reported that Billroth I reconstruction has less effect on diabetes compared to Billroth II and Roux-en-Y reconstruction. While little is known about different effects of Billroth II and Roux-en-Y procedure, a study retrospectively show that Roux-en-Y procedure has significantly higher rate of T2DM remission than Billroth II procedure. Investigators conduct a randomized controlled trial to control possible confounders arising from diverse metabolic effects of cancer and minimize differences in treatment regimen among patients.

Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

A Randomized Controlled Trial Comparing Billroth II Reconstruction Versus Conventional Roux-en-Y Reconstruction Versus Long Limb Roux-en-Y Reconstruction for Glycemic Control in Patients With Concurrent Type 2 Diabetes and Gastric Cancer

The proportion of subjects with HbA1c \< 6.5% without diabetes medications

The number of days from randomization to the visit date when HgA1c is first observed to be \< 6.5% (or 6.0%) post-randomization

Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c ≤ 6% (with or without diabetes medication)

Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c \<6.5% (with or without diabetes medication)

Percent change in total cholesterol at 12 months, 24 months, 36 months

Percent change in triglyceride at 12 months, 24 months, 36 months

Percent change in high-density lipoprotein (HDL) at 12 months, 24 months, 36 months

Percent change in Low-density Lipoprotein (LDL) at 12 months, 24 months, 36 months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery	NCT04284943	Gastric Cancer Diabetes Mellit...	Long limb Roux-... Conventional Ro... Billroth II rec...	20 Years - 69 Years	Korea University Anam Hospital
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery	NCT04284943	Gastric Cancer Diabetes Mellit...	Long limb Roux-... Conventional Ro... Billroth II rec...	20 Years - 69 Years	Korea University Anam Hospital

Spots Global Cancer Trial Database for billroth ii reconstruction after subtotal gastrectomy